Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction
Application of Platelet-Rich Fibrin Consolidated Bone Substitutes in Alveolar Ridge Preservation: A Randomized Controlled Study
This study uses a natural material called Platelet-Rich Fibrin (PRF) to help improve healing after tooth removal. PRF is made from your own blood. A small amount of blood is taken from your arm and spun in a machine to make a thick, sticky layer full of platelets. These platelets help your body heal. PRF acts like a "natural bandage" and may help your gums and bone heal faster. Because it comes from your own body, it is safe and lowers the chance of infection or problems.
The goal of this research is to see if adding PRF to a bone graft (used to fill the tooth socket after extraction) can help the area heal faster and grow more new bone.
If you join this study, it will last about 4 months. You will have two teeth removed, and each socket will get a different treatment:
- One socket (test side) will get PRF + bone graft (this combination is also called "sticky bone").
- The other socket (control side) will get a bone graft + a covering called a barrier membrane (made of collagen).
We will compare how well the two sides heal by looking at:
- How the gums close over the area
- How much pain you feel
- How much the bone changes
- How much new bone grows You will come to the clinic for about 9 visits in total. These visits are part of your regular treatment, along with a few extra steps for the study.
One possible risk is bruising or soreness from the blood draw. If we cannot collect enough blood (about 60-80 ml) because your veins are too small or hard to find, you will not continue in the study, and both sockets will be treated using the control method (bone graft + membrane).
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Siraj Zabadi, DDS
- 電話番号：614-206-0298
- メール：Zabadi.1@osu.edu
研究連絡先のバックアップ
- 名前：Guo-Liang Cheng, DDS, MS
- メール：cheng.712@osu.edu
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients of age between 18-80.
- Non-smokers or former smokers with at least a 5-year successful cessation history.
- Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction and cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
- Patients treatment planned for extraction and ridge preservation for at least 2 non-adjacent single-rooted teeth.
Exclusion Criteria:
- Current smokers, smokers who have quit <5 years prior to study entry.
- Pregnant or lactating women
- Patients with substance or alcohol abuse
- Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
- Other systemic conditions or medications affecting wound healing.
- Poor plaque control with plaque score > 20%
- Active/untreated odontogenic and periodontal infections
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：PRF-solidified bone graft
Extraction socket is grafted with freeze-dried bone allograft (FDBA) mixed with autologous platelet-rich fibrin (PRF) to form a cohesive graft, without placement of a barrier membrane.
|
Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.
Human-derived bone graft material used to fill extraction sockets for ridge preservation
|
|
アクティブコンパレータ：Bone Graft With Collagen Membrane
Extraction socket is grafted with freeze-dried bone allograft (FDBA) and covered with a resorbable collagen membrane for ridge preservation.
|
Human-derived bone graft material used to fill extraction sockets for ridge preservation
Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in alveolar ridge dimensions
時間枠：4 months after ridge preservation (prior to implant placement)
|
Change in alveolar ridge width and height will be measured by superimposing baseline and 4-month follow-up cone-beam computed tomography (CBCT) images at standardized cross-sectional locations corresponding to the extraction sites.
|
4 months after ridge preservation (prior to implant placement)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Wound healing (re-epithelialization)
時間枠：1, 2, 3, and 4 weeks after ridge preservation
|
Soft tissue wound closure over extraction sites will be assessed using serial intraoral scans and analyzed to quantify changes in wound area over time.
|
1, 2, 3, and 4 weeks after ridge preservation
|
|
Percentage of new bone formation
時間枠：4 months after ridge preservation (at implant placement)
|
Bone core biopsies obtained at implant placement will be analyzed histologically to determine the percentage of newly formed bone within the grafted sites.
|
4 months after ridge preservation (at implant placement)
|
|
Crestal soft tissue thickness
時間枠：4 months after ridge preservation (at implant placement)
|
Soft tissue thickness at the alveolar crest will be measured clinically using a periodontal probe at the time of implant placement.
|
4 months after ridge preservation (at implant placement)
|
|
Postoperative pain score
時間枠：1, 2, 3, and 4 weeks after ridge preservation
|
Participant-reported pain will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
|
1, 2, 3, and 4 weeks after ridge preservation
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY20250322
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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